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Ensuring Fair Access: SB 269 Protects Affordable Medication for Low-Income Patients

Client Alert

Senate Bill 269 (SB 269), introduced on May 14, 2024, will ensure that 340B covered entities, including Federally Qualified Health Centers, Ryan White Clinics, disproportionate share hospitals, and Title X clinics, can acquire 340B drugs without facing undue restrictions or discriminatory practices from drug manufacturers and distributors. This protection is crucial for 340B covered entities to continue to provide affordable medications and comprehensive services to low-income patients.

What is the Federal 340B Drug Pricing Program?
Under the 340B Program, Federal law permits covered entities to buy outpatient prescription drugs from drug manufacturers at a discount. In exchange for committing to serve historically marginalized and underserved patients, payors reimburse covered entities at retail rates, allowing the covered entity to realize a savings. Covered entities reinvest that savings into their services and programs; the savings covered entities achieve through the 340B Program helps them stretch scarce federal resources. Without the 340B Program, covered entities will not be able to provide care to vulnerable populations.

What Does SB 269 Do?
Prohibits Restrictive Practices: SB 269 prohibits drug manufacturers, re-packagers, third-party logistics providers, and wholesale distributors (and their agents or affiliates) from denying, prohibiting, restricting, discriminating against, or otherwise limiting the acquisition or delivery of 340B drugs to covered entities, unless required by Federal law. The law would prohibit drug manufacturers and others from limiting covered entities’ use of contract pharmacies, a practice that interferes with the ability of patients who rely on covered entities to access needed health care services and affordable prescription drugs. Under the bill, these parties also cannot require 340B covered entities to submit claims or utilization data as a condition for acquiring or delivering 340B drugs, unless such data sharing is mandated by Federal law.

Enforcement and Penalties: Under the bill, violations of these provisions may result in a civil penalty of $50,000 per violation, as well as referral to the Ohio Board of Pharmacy for further action.

Please contact BMD Healthcare Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com with any questions about SB 269 or the 340B drug pricing program, or to weigh in with your lawmaker about the bill.


HHS Revokes Public Comment Requirement on Certain Policy Changes

The U.S. Department of Health and Human Services (HHS) has revoked the Richardson Waiver, eliminating the requirement for public notice and comment on certain policy changes. This decision allows HHS to implement new policies more quickly, potentially affecting healthcare funding rules like Medicaid work requirements. While it speeds up policymaking, it also reduces opportunities for stakeholder input, raising concerns over transparency and unintended consequences for healthcare providers, states, and patients.

Don't Get Caught Dazed and Confused: Another Florida Court Weighs in on Employer Obligations to Accommodate Medical Marijuana Use

A Florida trial court ruled in Giambrone v. Hillsborough County that employers may need to accommodate off-duty medical marijuana use under the Florida Civil Rights Act (FCRA). This contrasts with prior rulings and raises new compliance challenges for employers. With the case on appeal, now is the time to review workplace drug policies.

Corporate Transparency Act to be Re-evaluated

Recent federal rulings have impacted the enforceability of the Corporate Transparency Act (CTA), which took effect on January 1, 2024. While reporting requirements were briefly reinstated, FinCEN has now paused enforcement and is reevaluating the CTA. Businesses are no longer required to submit reports until further guidance is issued. For updates and legal counsel, contact BMD Member Blake Gerney.

Ohio Recovery Housing Operators Beware: House Bill 58 Seeks to Make Major Changes

Ohio House Bill 58 proposes significant changes to recovery housing oversight, granting ADAMH Boards authority to inspect and investigate recovery residences. The bill also introduces a Certificate of Need (CON) program, requiring state approval for major facility changes. OMHAS will assess applications based on cost, quality, accessibility, and financial feasibility. The bill also establishes a recovery housing residence fund to support inspections. For more information, contact BMD attorneys Daphne Kackloudis or Jordan Burdick.

January 2025 Notice of Proposed Rulemaking Brings Notable Changes to HIPAA Security Rule

In January 2025, the U.S. Department of Health and Human Services proposed amendments to the HIPAA Security Rule, aiming to enhance cybersecurity for covered entities (CEs) and business associates (BAs). Key changes include mandatory compliance audits, workforce training, vulnerability scans, and risk assessments. Comments on the proposed rule are due by March 7, 2025.